Published: 12 - Wwwmedia.supplychain.nhs.uk

Publication Type(s): Journal Article PubMedID: 19863029 Author(s): Dougherty L Database: PubMed commonly used for subcutaneous and intramuscular injection. A review of the Royal Marsden manual of nursing procedures highlighted the use of luer slip syringes for subcutaneous and intramuscular injection. The Royal College of Nursing Standards for Infusion Therapy (4th Edition, 2016) and the Journal of Infusion Nursing Infusion Therapy Standards of Practice (Jan/Feb 2016) were reviewed with no specific guidance to the use of a luer slip syringe identified. NHS Scotland had published a good practice statement for the preparation of injections in near patient areas, including clinical and home environments in 2002. This highlighted a number of practice statements regarding protection of sterility to syringes prior to use. It stated that clinical staff should peel wrappers from needles and syringes – do not push through wrappers as this will result in heavy particulate contamination. A search of the NHS Central Alerting System (CAS) returned 27 results for the keyword syringe but none were related to the specific use of luer slip syringes. National procurement provider specification Hypodermic luer slip syringes are available in a range of sizes from 1ml-50/60ml with main volume usage in 2ml, 5ml, 10ml and 20ml. The current National procurement provider’s (NHS Supply Chain) framework specification allows for suppliers to submit either a 2-piece or 3 piece luer slip design for consideration and at present two suppliers provide a 2-piece syringe to the NHS. 2-Piece syringes consist of a barrel and plunger and use an alternative lubricant usually of fatty acid amides to help with plunger movement. Volumes of 2-piece syringe usage are low in the NHS with it accounting for less than 2% of the national volume. We were unable to identify through the literature or clinical engagement a reason to use 2-piece or 3 piece syringes but on the basis of NHS consumption we have excluded 2-piece syringes from this report and these will be reviewed separately if required. 8 Clinical review: syringes hypodermic luer slip –Final (V1.0) 12.2016

Product suppliers and manufacturers Request for information were sent to all suppliers on framework. All suppliers provided some level of information from product brochure through to technical datasheets and compliance with standards. Best practice guidelines The existing specification was reviewed to confirm the regulatory and technical requirements that suppliers are required to meet as part of the specification and confirmation from the national provider that these were in place. We could not identify any particular recommendations for use of concentric or eccentric tip other than this was different by supplier but in line with the required standard. This along with information from a number of sources was gathered to provide a basis for clinical discussions about the use of luer slip syringes with the NHS. NHS clinical engagement In order to develop a shared vision of what a hypodermic luer slip syringe should offer, several methods of engagement were used. There are several stages to the clinical engagement process starting with a mapping exercise to determine who should be involved. For our purposes in this stage of the report we focused on clinical staff who are either a) recognised as subject experts, and / or b) recognised regular users of the devices in their clinical practice. These are some of the approaches we have used: regional and national face-to-face events with NHS clinical colleagues focussed visits to NHS clinicians regional and national face to face events website subscription attendance at specialist network events attendance at NHS Business Services Authority events web based surveys and e-engagement tools (e.g. email, WebEx, portal based surveys) To build a broad caucus of attendees at our events communications were distributed inviting Trusts to nominate clinical colleagues to attend a series of regional group events; these were hosted by NHS organisations around England to enable the widest possible access. This enabled any pre-existing regional variance to be set aside. 9 Clinical review: syringes hypodermic luer slip –Final (V1.0) 12.2016

Details of the information gathered were recorded in booklet form from the open events, transcribed and then used together with the evidence gathered at the previous project stage to inform a list of clinical criteria against which the product has been tested. The questions used to stimulate discussion and further information gathering were developed following a questionnaire sent to the clinical procurement specialist network which represents nurses and other clinicians working in procurement roles at NHS Trusts, regional procurement hubs and NHS Supply Chain. Examples of the evidence gathering criteria questions posed for hypodermic luer slip syringes are shown in the table below. NHS clinician colleagues were also asked to score the importance of each criteria, with 0 as having no important and 10 as having critical importance. Syringes Hypodermic Luer Slip Criteria / questions Any specific packaging requirements for this product? Any specific issues with how we open and prepare this product for clinical use? How important are the markings and grading? How important is it that you can still attach a label, whilst still seeing the markings? How important is a smooth plunger action? How important is it that you can be confident in the accuracy of dosing? How important is it that you can attach a range of needles safely and securely? How important is secure universal fitting with needle-free access devices? How important is the feel, shape and size of the wings and plunger top to enable accurate single handed use? How important is it that you can operate the syringe with a gloved hand? Does/would a ridged or textured plunger top make a difference? Does/would a slightly indented plunger top make a difference? Any specific disposal criteria for this product? What would make a “perfect” product if you could design your own based on your clinical experience and knowledge? What features would it have? Figure 2 - Examples of the evidence gathering criteria questions posed for Hypodermic Luer Slip Syringes 10 Clinical review: syringes hypodermic luer slip –Final (V1.0) 12.2016

Clinical criteria The data received from all the NHS clinical engagement events, alongside the data collected from individual experts, was assimilated into a series of clinical criteria. A clinical criterion is defined as a principle or standard by which products may be evaluated. It is an objective statement which describes the clinician’s requirements for the product. The synthesised criteria were then validated by clinical engagement workshop attendees and clinical experts as likely to produce useful outcomes. CLINICAL CRITERIA – Syringes hypodermic luer slip Packaging The product type, size, lot number and expiry date is simple for staff to identify on the external packaging The external packaging is of a robust construction for storage and simple to access for removal of products The product type, size, lot number and expiry date is simple to identify on the syringe wrapper The syringe wrapper should give a clear indication of how to open Opening and Preparation for Clinical Use The syringe can be opened quickly whilst protecting any sterility requirements Clinical Use The volume numbers and measured graduation lines are clear, visible and easy to read for clinical staff There is space to apply a drug label in certain clinical situations without compromising the visibility of graduations - This will only be a criteria for 2ml/5ml/10ml/20ml sizes in Luer Slip The design should enable staff to use the syringe with a one-handed technique The syringe should easily draw up and dispense a range of solutions commonly used in clinical practice The syringe should accept a range of hypodermic, blunt and filter drawing up needles The plunger should not easily be accidentally removed when drawing up a solution The handling and use of the syringe should not be affected by wearing of medical gloves Disposal after use A range of hypodermic, filter & blunt drawing up needles that are secured to a luer slip syringe can be removed safely using a sharps container needle remover lid. Figure 3 – NHS Clinical Criteria Luer Slip Syringes October 2016 11 Clinical review: syringes hypodermic luer slip –Final (V1.0) 12.2016

Product evaluation Evaluation methodologies are defined for each and every clinical criteria. They reflect a simulated clinical environment. All products were supplied in a ‘ward ready’ unit of issue as would be found by clinical staff on accessing a store area in their clinical environment. The tests were formulated to move through the key aspects of product use using the NHS Clinical Evaluation Team product cycle: Packaging Opening Product cycle Disposal Clinical use Figure 4 – NHS Clinical Evaluation Team product cycle The evaluation product was ordered and picked from NHS distribution centres so we were reviewing lot numbers in use across the NHS. Products evaluated have been stored post evaluation for a period of three months after publication of this review. Practicing NHS clinical staff were invited to review NHS Supply Chain product in accordance with the developed criteria. It was not possible to “blind” the evaluations; however the product to be evaluated was independently picked and prepared for evaluation by colleagues who were not otherwise involved in the process. Each clinical evaluator entered data independently and without inter-rater comparison into their own workbook. These were then collated, reviewed and summarised by the clinical specialist lead for the project. A subjective score was given against each of the defined criteria from 0-3 as follows: Score 0 1 2 3 Meaning This does not meet the criteria This partially meets the criteria This meets the criteria This exceeds the criteria Figure 5 – NHS Clinical Evaluation Team scoring methods 12 Clinical review: syringes hypodermic luer slip –Final (V1.0) 12.2016

These numerical scores across all evaluators were totalled and a mean value determined. This mean value has then been converted into a star rating against the individual compliance against the criteria (see matrix below). The mean values convert to a start rating in accordance with the following table: Point scored 0 to 0.99 1 to 1.24 1.25 to 1.74 1.75 to 2.24 2.25 to 2.74 2.75 to 3 Star value 0 star 1 star 1.5 stars 2 stars 2.5 stars 3 stars Figure 6 – conversion of mean scores to star rating All supplemental products used in the evaluation are in use in the NHS and available through the national catalogue (e.g. clinical waste containers, gloves, drug labels and syringes). Evaluators were encouraged to also make comments where they felt necessary to provide rationale for their scoring and answers. The results obtained have been validated by the team’s moderation committee for consistency of scoring and interpretation. These results are presented in the product assessment results matrices below. Product assessment results The below product assessment results pages show the tested clinical criteria listed vertically down the left hand side of the page with the tested device found horizontally across the top of the reports. The accompanying photographs were taken during evaluation. This is a photograph of the sample product provided for evaluation. Lot numbers were recorded and samples have been retained in storage following the completion of evaluation. The products represented are the range of suppliers and brands available through the NHS national procurement provider’s framework as of August 2016. 13 Clinical review: syringes hypodermic luer slip –Final (V1.0) 12.2016

Supplier Name - Terumo Product Code & Description Score 0 1 2 3 FWC531 Syringe Hypodermic Tuberculin 1ml 100 Graduations at 0.01ml Increments Luer Slip Terumo FWC407 Syringe hypodermic concentric luer slip 2 to 2.5ml Terumo SS02S1 FWC102 Syringe hypodermic concentric luer slip 5ml with 0.2ml graduations Terumo SS05S1 FWC103 Syringe hypodermic eccentric luer slip 10ml Terumo SS10ES1 FWC104 Syringe hypodermic eccentric luer slip 20ml Terumo SS20ES1 FWC539 Syringe hypodermic eccentric luer slip 30ml Terumo SS30ESE1 FWC421 Syringe hypodermic eccentric luer slip 50ml Terumo SS50ES1 Meaning This does not meet the criteria The partially meets the criteria This meets the criteria This exceeds the criteria Scoring Matrix Unit of issue Graduation lines measured in CLINICAL CRITERIA - IV Luer Slip 3 Piece Syringes The product type, size, lot number and expiry date is simple for staff to identify on the external packaging Box 100 Box 100 Box 100 Box 100 Box 50 Box 50 Box 25 0.01ml 0.1ml 0.2ml 0.2ml 1ml 1ml 1ml CET Evaluation Rating CET Evaluation Rating CET Evaluation Rating CET Evaluation Rating CET Evaluation Rating CET Evaluation Rating CET Evaluation Rating (1.8) (1.8) (1.8) (1.8) (1.8) (1.8) (1.8) The external packaging is of a robust construction for storage and simple to access for removal of products (2.0) (1.8) (2.0) (2.0) (2.0) (2.0) (2.0) The product type, size, lot number and expiry date is simple to identify on the syringe wrapper (1.6) (1.6) (1.6) (1.6) (1.6) (1.4) (1.6) The syringe wrapper should give a clear indication of how to open (2.2) (2.2) (2.2) (2.2) (2.2) (2.2) (2.2) The syringe can be opened quickly whilst protecting any sterility requirements (2.2) (2.2) (2.2) (2.2) (2.2) (2.2) (2.2) The volume numbers and measured graduation lines are clear, visible and easy to read for clinical staff (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) There is space to apply a drug label in certain clinical situations without compromising the visibility of graduations - This will only be a criteria for 2ml/5ml/10ml/20ml sizes in luer slip Not Applicable Not Applicable Not Applicable The design should enable staff to use the syringe with a one-handed technique (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) The syringe should easily draw up and dispense a range of solutions commonly used in clinical practice (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) The syringe should accept a range of hypodermic, blunt and filter drawing up needles (2.0) (2.0) (2.0) (2.0) (2.0) (1.8) (2.0) The plunger should not easily be accidentally removed when drawing up a solution (2.2) (2.2) (2.0) (2.2) (2.2) (2.2) (2.0) The handling and use of the syringe should not be affected by wearing of medical gloves (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) A range of hypodermic, filter & blunt drawing up needles that are secured to a luer slip syringe can be removed safely using a sharps container needle remover lid. (1.6) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) 14 Clinical review: syringes hypodermic luer slip –Final (V1.0) 12.2016

Supplier Name - Medicina Product Code & Description Score 0 1 2 3 FWC345 Syringe hypodermic concentric luer slip 1ml Medicina IVS01 FWC346 Syringe hypodermic concentric luer slip 3ml Medicina IVS03 FWC347 Syringe hypodermic concentric luer slip 5ml Medicina IVS05 FWC348 Syringe hypodermic concentric luer slip 10ml Medicina IVS10 FWC409 Syringe hypodermic eccentric luer slip 10ml with eccentric tip Medicina Ltd IVS10E FWC349 Syringe hypodermic eccentric luer slip 20ml Medicina IVS20 FWC351 Syringe hypodermic eccentric luer slip 30ml Medicina IVS30 FWC436 Syringe Hypodermic Eccentric Luer Slip 60ml Medicina IVS60 Meaning This does not meet the criteria The partially meets the criteria This meets the criteria This exceeds the criteria NHS CET Scoring Matrix Unit of issue Graduation lines measured in CLINICAL CRITERIA - IV Luer Slip 3 Piece Syringes Box 100 Box 100 Box 100 Box 100 Box 100 Box 50 Box 30 Box 30 0.01ml 0.1ml 0.2ml 0.2ml 0.2ml 1ml 1ml 1ml CET Evaluation Rating CET Evaluation Rating CET Evaluation Rating CET Evaluation Rating CET Evaluation Rating CET Evaluation Rating CET Evaluation Rating CET Evaluation Rating The product type, size, lot number and expiry date is simple for staff to identify on the external packaging (2.2) (2.2) (2.2) (2.2) (2.2) (2.2) (2.2) (2.2) The external packaging is of a robust construction for storage and simple to access for removal of products (2.4) (2.4) (2.4) (2.4) (2.4) (2.4) (2.2) (2.4) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** (1.4) (2.0) (2.0) (1.8) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) (2.0) The product type, size, lot number

Syringe Hypodermic 10ml luer slip 42% Syringe Hypodermic 20ml luer slip 18% Syringe Hypodermic 30ml luer slip 0% Syringe Hypodermic 50/60ml luer slip 1% Figure 1 Syringe volume by size- Nov 16 . Whilst there are no clear recommendations in the literature on when to use a luer slip vs. a luer lock syringe, the engagement with clinicians across .